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K Number
K030271
Device Name
VENTLAB BACTERIAL FILTER, MODEL BF100
Manufacturer
VENTLAB CORP.
Date Cleared
2003-07-07

(161 days)

Product Code
CAH
Regulation Number
868.5260
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.

Device Description

Ventlab Bacterial Filter BF100

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Bacterial Filter BF 100". It states that the device is substantially equivalent to a predicate device, allowing it to be marketed. However, this document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

Therefore, I cannot provide the requested information. The provided text is purely a regulatory approval letter and does not include the technical details of a study or performance evaluation.

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).